Validation of Insulin Protocol for Glucocorticoid-induced Hyperglycemia in Diabetic Oncology Patients

The Washington University

Status and phase: Completed; Early Phase 1

Conditions: Hyperglycemia; Lymphoma; Diabetes Mellitus, Type 2

Treatments: Biological: Insulin protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT02012465

201306071

Details and patient eligibility

About

There are no guidelines for the management of glucocorticoid- (henceforth steroid) induced elevated blood sugars (henceforth hyperglycemia). Oncology ward patients have particularly high rates of hyperglycemia and are frequently exposed to high dose steroid therapy. A prior study by Muthala et al. (unpublished data) found a relationship between insulin requirements needed to maintain normal blood sugars, patient weight, and mg of steroid administered. In this pilot study, through an endocrine consult team, a weight-based, steroid dose-based insulin protocol will be implemented for the management of hyperglycemia in lymphoma patients requiring high dose steroid therapy, with the goal of reducing hyperglycemia incidence.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For diabetics enrolled on admission:

Inclusion Criteria:

• Age ≥ 18 years old
• Type 2 diabetes mellitus treated with insulin secretagogues or insulin prior to hospitalization
• Diagnosis of lymphoma
• Plan to treat with steroids of minimum equivalent of 20 mg prednisone per day
• Hospitalized for at least 48 hours
• Decision-making capacity to provide own consent

Exclusion Criteria:

• Type 1 diabetes
• Any contraindication to insulin therapy
• Patients only on single agent therapy such as metformin, thiazolidinediones (TZDs), Dipeptidyl peptidase-4 (DPP4) inhibitors, or Exenatide®, for safety concerns
• Insulin requirement of >1.5 units of insulin/kg
• If a patient required ICU stay during the hospitalization, data from 12 hours before, during, and 12 hours after ICU stay will be omitted to avoid confounding of the effect of critical illness on glycemic control
• Pregnancy, confirmed with a urine b-human chorionic gonadotropin (HCG) (for all women between the age of 18 and 60 years old)

Patients who develop a blood glucose > 235 mg/dL after admission will be eligible for study enrollment based on the following:

Inclusion criteria:

• Age ≥ 18 years old
• Diagnosis of lymphoma
• Plan to treat with steroids of minimum equivalent of 20 mg prednisone per day
• Will be hospitalized for at least an additional 48 hours
• Decision-making capacity to provide own consent

Exclusion criteria:

• Any contraindication to insulin therapy
• If a patient required ICU stay during the hospitalization, data from 12 hours before, during, and 12 hours after ICU stay will be omitted to avoid confounding of the effect of critical illness on glycemic control
• Pregnancy, confirmed with a urine b-HCG (for all women between the age of 18 and 60 years old)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Insulin protocol

Experimental group

Description:

For diabetic patients, as part of the initial chemotherapy orders on admission, the following will be calculated by the primary oncologist to determine the amount of neutral protamine Hagedorn (NPH) insulin needed to cover steroid use in prednisone equivalents (all insulin in this study is to be administered subcutaneously): * Use 0.1 (mg of prednisone equivalent - 20)/20 x weight (kg) to estimate total insulin in 24 hours (Total daily dose (TDD)) * Total daily NPH dose will be divided equally based on the frequency of steroid administration, and given with each steroid dose. For nondiabetic participants with hyperglycemia recruited during admission, the inpatient oncology team will consult the endocrine team within 24 hours of eligibility for NPH dosing as above.

Treatment:

Biological: Insulin protocol